Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Gross total resection (Yes or No)
研究概览
简要总结
The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR) without causing new neurological deficits1-8. Intraoperative navigated high resolution ultrasound (US) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. The aim of this study was to investigate whether intraoperative guided surgery leads to a higher rate of GTR, when compared with standard non-ultrasound guided surgery.
详细描述
Study design:
The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.
Study population:
Fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan.
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Gross total resection (yes/no) on post-operative T1 postcontrast MRI scans will be evaluated by a neuroradiologist who is blinded for the treatment arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of 18 years or older
- •Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma
- •Preoperative intention to perform gross-total resection of the enhancing tumor
- •Written informed consent conform ICH-GCP
排除标准
- •Tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection
- •Multifocal contrast enhancing lesions
- •Pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke)
- •Inability to give consent because of dysphasia or language barrier
结局指标
主要结局
Gross total resection (Yes or No)
时间窗: within 48 hours after surgery
Gross-total resection (yes vs. no): No residual contrast enhancement on post-operative MRI scans; 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans.
次要结局
- Neurological outcome (Karnofsky Performance status)(within 1 week after surgery)
- Quality of Life (QLQ BN20 questionnaires)(1, 3 and 6 months after surgery)
- Quality of Life (QLQ C30 questionnaires)(1, 3 and 6 months after surgery)
- Surgery associated neurological deficits (National Institutes of Health Stroke Scale)(1 month after surgery)
- Extent of resection (%)(within 48 hours after surgery)
- Survival (time in days)(status will be checked 15 months after surgery)
研究者
A.J.P.E. VIncent
neurosurgeon, principal investigator
Erasmus Medical Center